Quality Assurance Operations Specialist (Seishin Plant, Kobe)

About the role

Lilly is hiring for a Quality Assurance Operations position (grade P1-P3) at its Seishin plant in Kobe City. The role covers product quality assurance of pharmaceutical and medical device manufacturing processes and product testing at the site.

Key responsibilities

• GMP compliance for new product launches, building quality assurance systems and coordinating with internal stakeholders
• Build quality standards and assurance systems for the Japanese manufacturing site based on GQP and GMP, working with domestic and global departments
• Review manufacturing and testing records, and manage deviations, change controls and validation
• Investigate and report quality information and product quality issues
• Support regulatory inspections and audits at the site and handle batch release activities
• Carry out quality improvement activities together with overseas manufacturing sites

Required profile

• At least 3 years of experience in manufacturing, quality testing or quality assurance in the pharmaceutical, medical device, food, cosmetics or chemical industry
• Native-level Japanese and basic English, with a willingness to improve English
• Commute within 90 km of the nearest station and 90 minutes by public transport; relocation is generally expected beyond this range (company-leased housing available)

Required skills

• Pharmacist license (desirable)
• Knowledge of GMP and GQP

What we offer

• Competitive salary with annual salary increases and a performance-based bonus paid in March
• Housing allowance, commuting allowance and other allowances
• Working hours 8:45 AM to 5:30 PM, with flextime and a 4-hour minimum daily requirement
• Overtime pay for non-exempt staff, two days off per week, national holidays and annual leave
• Health, employment, workers' compensation and pension insurance, and a re-employment system until age 65